MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4-RT 15MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	74027236
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka surgery had been performed on (b)(6) 2020, a jrny ii bcs xlpe art isrt sz 3-4-rt 15mm was removed and replaced due to patient fall.The adverse event was addressed with a revision surgery on (b)(6) 2021.No patient injuries or other complications were reported.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, although no clinical/medical records were received; it was reported that the revision was a consequence of the patient¿s fall.It cannot be concluded that the revision was related to a malperformance of the implant or an implant failure.The patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.No further clinical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 3-4-RT 15MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11722108
• Report Number: 1020279-2021-03414
• Device Sequence Number: 17085021
• Product Code: JWH
• UDI-Device Identifier: 00885556179260
• UDI-Public: 00885556179260
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/25/2025
• Device Model Number: 74027236
• Device Catalogue Number: 74027236
• Device Lot Number: 15JM18944
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 04/25/2021
• Supplement Report FDA Received Date: 09/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention